Sorafenib in Elderly mRCC

Completed

• Conditions: Carcinoma, Renal Cell
• Interventions: Drug: Sorafenib (Nexavar, BAY43-9006)

• Registration Number: NCT01728948
• Lead Sponsor: Bayer

Brief Summary

This prospective, single arm, multi-center pilot study includes 120 mRCC patients over 65 years, no prior systemic treatment, determined to be candidates for systemic therapy by the investigator. The treatment with Sorafenib should comply with the recommendations written in the local product information. The primary endpoint is overall survival. The secondary endpoints including other effectiveness points, safety and patients characteristics. With 120 completed patients, if the observed survival rate at 12 months is 60%, the width of a 95% confidence interval will be approximately 18%.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-14
• Study First Submitted QC: 2012-11-14
• Study First Posted: 2012-11-20
• Study Start: 2013-01-06
• Primary Completion: 2016-01-04
• Study Completion: 2017-01-16
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-08
• Last Update Posted: 2017-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients with histologically/cytologically diagnosed metastasis RCC who are candidates for systemic therapy and have decided to accept Sorafenib treatment.
• >=65 years of age
• Patients who have signed the informed consent
• Patients with a life expectancy of ≥12 weeks
• No prior systemic treatment

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Exclusion Criteria

• The approved local product label must be followed for the exclusion criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Sorafenib (Nexavar, BAY43-9006)	-

Primary Outcome Measures

Name	Time	Method
Overall survival	up to 2.5 years

Secondary Outcome Measures

Name	Time	Method
Progression free survival by the Response Evaluation Criteria in Solid Tumor (RECIST) Criteria	up to 2.5 years
Disease control rate by the Response Evaluation Criteria in Solid Tumor (RECIST) Criteria	up to 2.5 years
Survival rate by one year	up to 1 year
Number of participants with adverse events (AE) and Serious adverse events (SAE) as a measure of safety and tolerability	up to 3.5 years
Patient characteristics (birthdate (at least year), sex, weight, height, etc)	up to 2.5 years
Response rate (RR)	up to 3.5 years
Time to first relief of clinical symptoms and physical signs	up to 3.5 years
Treatment pattern	up to 3.5 years